Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea

This is a single site, single arm open label study of Azelaic Acid foam 15% for the treatment
of moderate to severe papulopustular rosacea. All patients will apply Azelaic Acid foam twice
daily. At scheduled visits, high resolution equipment will be used to measure 3D
topographical values for elevation of papules and pustules to objectively evaluate reduction
of papulopustular lesions. Investigator and subject assessments will also be completed to
assess the level of rosacea at weeks 4,8 and 12.

Inclusion Criteria:

1. Male or female subjects age 18 or older.

2. Diagnosis of moderate to severe papulopustular rosacea with IGA of 3- moderate or
4-severe.

3. Presence of 12 - 50 inflammatory lesions and persistent erythema with or without
telangiectasia.

4. Subjects must read, understand, and sign the Informed Consent.

5. Subjects must be willing and able to comply with study procedures and visit schedule
requirements.

6. Women of childbearing potential that are willing to use an acceptable method of
contraception during the study.

Exclusion Criteria:

1. Active or localized or systemic infections.

2. Subjects must not be immunocompromised.

3. Known unresponsiveness or allergy to azelaic acid.

4. Subjects unlikely to comply with the protocol, e.g. mental condition rendering the
patient unable to understand the nature, scope, and possible consequences of the
clinical study, uncooperative attitude or unlikelihood of completing the study (e.g.
drug or alcohol abuse).

5. Subjects must not be pregnant or breastfeeding.

6. Presence of dermatoses that might interfere with the ability to diagnose and/or
evaluate rosacea.

7. Presence of other types of rosacea.

8. Laser surgery on the face for the treatment of telangiectasia or other conditions
within 6 weeks of study enrollment.

9. Use of medications or products for the treatment of rosacea or other medical
conditions within the following time periods prior to study enrollment. Use of these
medications will be prohibited during the trial.

Topical Prescription or Nonprescription medications 6 weeks Oral retinoids 6 months
Tetracycline (ex. doxycycline, minocycline 2 months Corticosteroids 4 weeks
Erythromycin or azithromycin 4 weeks Other systemic medications to treat rosacea 6
weeks

10. Refusal to sign the Informed Consent document or Photo Release document and/or refusal
to comply with all follow-up requirements.

11. Use of medications that are known to cause flushing.

12. Dose changes in the last 90 days or initiation of beta-blockers, vasodilators,
vasoconstrictors, nonsteroidal anti-inflammatory drugs, hormone therapy, and/or other
drugs known to cause acneform eruptions.